Danilo Neri

Principal Consultant with a demonstrated history of working in the pharmaceuticals industry and certified PDA Auditor in Computer Products Supplier Auditing Process Model since 2003. Currently Vice President Operations and Partner of PQE Group, leading quality service provider for Life Science since 1998, Board Director at the PDA Italy Chapter, and Corporate Trainer for FDA. Main expertise areas: Data Integrity Assurance, FDA/EMA/Anvisa/PMDA Inspection Support, EU and US GMP/GDP, Software Life Cycle (IEC 62304), AGILE practices in the development of medical device software (AAMI TIR45), Quality Management Systems (21 CFR Part 820 - ISO 13485) and Risk Management (ISO 14971).